Z-Rostudirsan Granted Priority Review; Incremental Positive as Momentum Builds

研报英文原文证据摘录

Z-Rostudirsan Granted Priority Review; Incremental Positive as Momentum Builds

Update

July 20, 2026 02:13 PM GMT

Morgan Stanley & Co. LLCMDyne Therapeutics Inc | North America Michael E Ulz

Equity Analyst

Z-Rostudirsen Granted Priority Mike.Ulz@morganstanley.comRohit Bhasin +1 212 761-4650

Research Associate

Rohit.Bhasin@morganstanley.com +1 212 761-0534

Review; Incremental Positive as Avraham Novick

Avi.Novick@morganstanley.com +1 212 761-2231

Momentum Builds

Dyne Therapeutics Inc (DYN.O, DYN US)

Biotechnology | United States of America

Key Takeaways Stock Rating Overweight

Industry View Attractive

Z-rostudirsen remains on track for a 1Q27 launch following BLA acceptance, Price target $47.00

priority review status, and a Jan 21, 2027 PDUFA date. Shr price, close (Jul 17, 2026) $23.74

Mkt cap, curr (mm) $3,918

Z-rostudirsen uses Q4W dosing versus weekly for the current standard of care, 52-Week Range $25.00-8.88

supporting a more convenient regimen alongside greater dystrophin expression.

Global Ph3 FORZETTO confirmatory trial continues for z-rostudirsen to support

conversion to full approval and launch prep remains ongoing.

We view BLA acceptance under priority review as an important hurdle and expect

momentum to build ahead of multiple key catalysts in 1Q27; Reiterate

overweight.

Z-rostudirsen launch remains on track for 1Q27 following BLA acceptance and

Priority Review. Earlier today, Dyne announced that the FDA accepted for review

the Biologics License Application (BLA) for z-rostudirsen (DYNE-251) in DMD

patients amenable to exon 51 skipping, granted priority review, and assigned a

January 21, 2027 PDUFA target action date (press release). The BLA seeks

Accelerated Approval based on dystrophin as a surrogate endpoint, and mgt.